Selected Pharmacometric Reviews, Guidances, and Presentations
Selected Pharmacometric Reviews
- Truvada (NDA217520)
- RAXIBACUMAB (BLA125349)
- Mirabegron (NDA202611)
- Tamiflu (NDA21246)
- Indacateral (NDA22383)
- Fingolimod (NDA22527)
- Telaprevir (NDA201917)
- Boceprevir (NDA202258)
- Paliperidone Palmitate Injectable Suspension
- Vilazodone (NDA22567)
- Dabigatran (22512)
- NDA 200677 (Pasireotide) for Cushing's dsease
- NDA 21689 (Esomeprazole) for GERD
- NDA 20505 (Topiramate) for epilepsy
- Retrovir (zidovudine) Review
- BLA 125057 (Adalimumab) for ulcerative colitis:Clinical pharmacology (Pharmacometrics) presentation at the advisory committee meeting
- Valganciclovir hydrochloride Review
- NDA 203585 (Omacetaxine) for CML
- Aptivus (tipranavir) Review
- Atacand (candesartan cilexetil) Review
- Angiomax Injection (bivalirudin) Review
- Videx (didanosine) Review
- Promacta Review
- Cleviprex (clevidipine) review
- Clinical Pharmacology and Biopharmaceutics Review: Part 1
- Clinical Pharmacology and Biopharmaceutics Review: Part 5
- Clinical Pharmacology and Biopharmaceutics Review: Part 6
- Benznidazole
- Vabomere
- Delafloxacin
- Nusinersen
- Obiltoxaximab
- Natpara
- Edoxaban
- Eliglustat
- Suvorexant
- Simeprevir
Guidances
- End-of-Phase 2A Meetings
- Population Pharmacokinetics
- Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications
- E4 Dose-Response Information to Support Drug Registration
- International Conference on Harmonization (ICH) - Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF)
Presentations
- Pharmacometrics 2020 (Gobburu at ACoP)
- Learning from Prior Parkinson's Disease Clinical Trials (Bhattaram)
- Understanding Parkinson's Disease (Bhattaram)
- Non-Small Cell Lung Cancer (Wang) and Pediatrics (Jadhav) at Advisory Committee Meeting 2008
- Tedisamil Advisory Committee Background Material
- Anti-Infective Drugs Advisory Committee Meeting: Clinical Trail Designs for Community Acquired Pneumonia
- Fingolimod Advisory Committee Background Material
- Fingolimod Advisory Committee Slides (Lee)
- Use of PVRI for Approval in Pediatric PAH patients (Brar)
- Tetrabenazine Advisory Committee Background Material
- Tetrabenazine Advisory Committee Slides (Bhattaram)
- Argatroban Pediatrics (Gobburu)